Status unknownNCT04810234Updated Mar 22, 2021

Neural Correlates of tVNS

An observational study in fMRI, Transcutaneous Vagal Nerve Stimulation (tVNS) and Nucleus of the Solitary Tract (NTS), sponsored by Maastricht University Medical Center. Status unknown at 2 sites in 2 countries. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-22.

Sponsored by Maastricht University Medical Center · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Other
Time perspective: Cross-sectional
Enrollment: 16
Ages: 18 Years to 40 Years
Sex: Female

Study summary

Transcutaneous vagal nerve stimulation (tVNS) has been applied to a number of disease areas including visceral pain, depression, cluster headache and Alzheimer's disease. However, there is marked heterogeneity in these studies pertaining to i) the anatomical site of stimulation (neck, inner concha or tragus of ear), and ii) the waveform parameters of the stimulating impulse. This exploratory cross-sectional study will address these knowledge gaps by comparative functional neuroimaging of the neural correlates of tVNS with disparate anatomical sites and electrical waveform characteristics during rest in healthy participants.

Conditions studied

fMRI
Transcutaneous Vagal Nerve Stimulation (tVNS)
Nucleus of the Solitary Tract (NTS)

In context

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

Female healthy volunteers aged between 18-40 years

Inclusion criteria

Of female sex;
Healthy participants (defined as those without a pre-existing medical comorbidity)
Age between 18 and 40 years;
BMI between 18 and 30 kg/m2;
Women on oral contraceptives only
All subjects should be right-handed.
Inclusion will be determined on the basis of availability. Subjects should be able to attend for 2 scanning sessions.

Exclusion criteria

Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device, metal braces, tattoos and/or other metal objects;
History of major head trauma or head/brain surgery;
History of claustrophobia;
History of severe or chronic cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, haematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol;
Use of regular medication, including vitamin and iron supplementation, except oral contraceptives, within 14 days prior to start of the study;
Pregnancy, lactation, wish to become pregnant;
High alcohol consumption (>15 alcoholic units consumed per week);
Using drugs of abuse;
Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study;
Participants unable to provide informed consent
Participants with any systemic disease or medications that may influence the autonomic nervous system (e.g. beta-agonists or Parkinson's disease)
Current smokers or current use of nicotine in any other way (including E-cigarettes and patches)
History of clinical anxiety or depression, or a hospital anxiety or depression score >8
Participants whom score 8 or more on the HADS-questionnaire at study commencement
Patient whom have cardiovascular conduction problems
Patient with cochlear implants
Not meeting any of the inclusion criteria above
Any evidence of structural brain abnormalities examined by anatomical MRI will lead to exclusion

Study design

Observational model: Other
Time perspective: Cross-sectional
Enrollment: 16 participants (estimated)
Patient registry: No

Interventions

Devicetranscutaneous vagal nerve stimulation (tVNS)
Cervical and auricular transcutaneous stimulation of the vagus nerve

What researchers measure

Primary outcomes

Blood oxygenation level dependent (BOLD) signal activity in the CAN during tVNS
fMRI related outcome measure
Time frame: During stimulation (difference between stim on - stim off blocks)

Secondary outcomes

Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during auricular tVNS (parameter set 1)
fMRI related outcome measure
Time frame: During stimulation (difference between stim on - stim off blocks)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during cervical tVNS )(parameter set 1)
fMRI related outcome measure
Time frame: During stimulation (difference between stim on - stim off blocks)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during auricular tVNS (parameter set 2)
fMRI related outcome measure
Time frame: During stimulation (difference between stim on - stim off blocks)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during cervical tVNS (parameter set 2)
fMRI related outcome measure
Time frame: During stimulation (difference between stim on - stim off blocks)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during subliminal auricular tVNS (parameter set 1)
fMRI related outcome measure
Time frame: During stimulation (difference between stim on - stim off blocks)
Functional connectivity / Network Connectivity of CAN regions during "active tVNS" block [to all 5 points as identified above]
fMRI related outcome measure
Time frame: During stimulation (difference between stim on - stim off blocks)

Study locations

1 of 2 sites recruiting

Maastricht University Medical Center
Maastricht, 6229 ER, Netherlands
- A.B. Beckers, MD · Contact · ab.beckers@maastrichtuniversity.nl · 0433881844
- A.A.M. Masclee, Prof. MD. PhD · Principal investigator
- D. Keszthelyi, MD. PhD · Sub investigator
- A.B. Beckers, MD. · Sub investigator
- D. Ivanov, PhD · Sub investigator
- H.I.L. Jacobs, PhD · Sub investigator
Recruiting
Queen Mary University of London. Wingate Institute of Neurogastroenterology
London, United Kingdom
Active, not recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04810234
Lead sponsor: Maastricht University Medical Center
Collaborators: Wingate Institute of Neurogastroenterology
Responsible party: Sponsor
First posted: Mar 22, 2021
Start date: Nov 1, 2020
Primary completion: Jun 1, 2021 (estimated)
Completion: Jun 1, 2021 (estimated)
Last update: Mar 22, 2021

Study contacts

Abraham Beckers, MD

Contact

ab.beckers@maastrichtuniversity.nl

+31433881844

Ad Masclee, MD, PhD

principal investigator · Maastricht University Medical Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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